A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol - Tabular View

Tracking Information

First Received Date ^ICMJE

November 10, 2006

Last Updated Date

August 16, 2007

Start Date ^ICMJE

November 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00399178 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

Official Title ^ICMJE

A Randomised Open Controlled Parallel Group Multicenter Study to Evaluate the Efficacy and Safety of Norspan Versus Tiparol Retard in Subjects With Chronic Moderate to Severe OA Pain of the Hip and/or Knee.

Brief Summary

To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Drug: Transdermal delivery system

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

160

Completion Date

June 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

OA diagnosis
BS11 greater than or equal to 4 at base line
Not adequately pain relieved with 4,000 mg paracetamol daily

Exclusion Criteria:

Treated with high potent opioids for their OA pain
Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
Other chronic conditions requiring frequent analgesic therapy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00399178

Responsible Party

Study ID Numbers ^ICMJE

2006-003233-32, BUP4009

Study Sponsor ^ICMJE

Mundipharma AB

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

M Karlsson, Med

Unaffiliated

Information Provided By

Mundipharma AB

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP